EQUIPED-ADRD: Enhanced Quality in Primary Care for Elders With Diabetes and Dementia

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT03723707
Collaborator
National Institute on Aging (NIA) (NIH)
1,000
1
2
53.9
18.6

Study Details

Study Description

Brief Summary

The purpose of this study is to develop and test a care quality improvement intervention featuring use of consensus decisional guidance for the medical management of diabetes (DM) in patients with Alzheimer's disease and related dementia (ADRD) in primary care, provider (PCP) workflow enhancements supported by a panel manager(PM) for workflow support, electronic health record (EHR) decision support and feedback, and PCP collaborative learning.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: EQUIPED-ADRD Intervention
  • Behavioral: Control (CON)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Enhanced Quality in Primary Care for Elders With Diabetes and Dementia
Actual Study Start Date :
Dec 3, 2018
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention (INT)

(10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM)

Behavioral: EQUIPED-ADRD Intervention
(10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM)

Placebo Comparator: Control (CON)

During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general.

Behavioral: Control (CON)
Will use current guidelines for primary care treatment with Diabetes and Dementia

Outcome Measures

Primary Outcome Measures

  1. Proportion of Intervention patients reaching consensus target HbA1c [30 Months]

  2. Proportion of Control patients reaching consensus target HbA1c [30 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient must receive care at participating NYU FGP clinics.

  • Patient must be English or Spanish speaking.

  • Patient must have DM diagnosis.

  • Patient must have documented cognitive impairment or an ADRD diagnosis.

  • Patient must have someone who is identified as a family or friend who provides caregiving assistance.

Caregiver:
  • Caregiver must have adequate knowledge of identified patient and/or participate in that member's healthcare decisions.

  • Caregiver must be English or Spanish speaking.

  • Caregiver must demonstrate capacity to consent to research participation.

  • Caregiver must be at least 21 years old.

Exclusion Criteria:
Patient:
  • Patient does not receive care at participating NYU FGP clinics.

  • Patient is not 65 years and older.

  • Patient is not English or Spanish speaking.

  • Patient does not have DM diagnosis.

  • Patient does not have documented Cognitive impairment or an ADRD diagnosis.

  • Patient has severe dementia, other terminal illness with <6 months to live, and/or is hospice eligible.

  • Patient does not have a caregiver.

Caregiver:
  • Caregiver does not have adequate knowledge of identified patient and/or does not participate in that member's healthcare decisions.

  • Caregiver is not English or Spanish speaking.

  • Caregiver lacks capacity to consent to research.

  • Caregiver is under 21 years old.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Joshua Chodosh, MD, MSHS, FACP, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT03723707
Other Study ID Numbers:
  • s18-01166
  • 1R21AG057291-01
First Posted:
Oct 29, 2018
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2022